# K240685: Salvo® Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: May 6, 2024 after 55 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K853033 (1985). 222 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 225 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222362: Salvo® Spine System, Spine Wave, Inc. (2022) Summary page 4.
- K160003: Sniper (R) Spine System, Spine Wave, Inc. (2016) Summary page 4.

## Most influential descendants
- K260286: Dynamo™ Spinal Cement; Salvo® Spine System (2026), 0 descendants of its own
- K251131: Annex® 2 Adjacent Level System (2025), 0 descendants of its own

## Indications for use
The Salvo® Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used in a percutaneous approach with minimally invasive surgery (MIS) instrumentation, the Salvo® Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K240685
Methodology: https://510kreport.com/methodology